David Calcagno1, John A Rossi, Chi Ha. 1. Calcagno and Rossi Vein Treatment Center, Mechanicsburg, Pennsylvania 17050, USA. vasculardoctor@comcast.net
Abstract
PURPOSE: Radiofrequency ablation (RFA) of veins >12 mm in diameter has been a controversial subject since the first-generation device was submitted for Food and Drug Administration (FDA) approval. Veins >12 mm were excluded in the initial study. Many insurance carriers used >12 mm size as reason to not approve the procedure. As the concept of tumescent anesthesia was better communicated, RFA was used for large veins. The 12-mm size limit was not used in the studies for the newer ClosureFAST catheter approval, yet remains in force with some insurance companies. Our objective was to determine whether vein diameter >12 mm had effect on closure rates with the Closure-FAST catheter. METHODS: ClosureFAST RFA was used to eliminate saphenous reflux in consecutive cases in 1 center. Retrospective analysis was performed on prospectively gathered data. Veins were divided into < or =12 mm diameter (group A) or >12 mm diameter (group B). Duplex scans were scheduled for 2 to 5 days and 6 months postprocedure. RESULTS: A total of 338 great and small saphenous veins were treated, 246 saphenous veins in group A (mean 8 +/- 2 mm) and 96 in group B (mean 17 +/- 4 mm). Early duplex showed complete closure in 231 veins in group A (94%) and 92 veins in group B (96%; NS). The remaining veins showed partial closure with none showing retrograde flow. Six-month duplex scans were completed in 155 veins. Complete closure was seen in 110 veins in group A (98%) and 43 veins in group B (100%; NS). All veins partially open on early scan had closed by 6 months. The 2 veins open at 6 months in group A were closed on initial scan. CONCLUSIONS: Vein diameter >12 mm had no effect on closure rate with the ClosureFAST catheter.
PURPOSE: Radiofrequency ablation (RFA) of veins >12 mm in diameter has been a controversial subject since the first-generation device was submitted for Food and Drug Administration (FDA) approval. Veins >12 mm were excluded in the initial study. Many insurance carriers used >12 mm size as reason to not approve the procedure. As the concept of tumescent anesthesia was better communicated, RFA was used for large veins. The 12-mm size limit was not used in the studies for the newer ClosureFAST catheter approval, yet remains in force with some insurance companies. Our objective was to determine whether vein diameter >12 mm had effect on closure rates with the Closure-FAST catheter. METHODS: ClosureFAST RFA was used to eliminate saphenous reflux in consecutive cases in 1 center. Retrospective analysis was performed on prospectively gathered data. Veins were divided into < or =12 mm diameter (group A) or >12 mm diameter (group B). Duplex scans were scheduled for 2 to 5 days and 6 months postprocedure. RESULTS: A total of 338 great and small saphenous veins were treated, 246 saphenous veins in group A (mean 8 +/- 2 mm) and 96 in group B (mean 17 +/- 4 mm). Early duplex showed complete closure in 231 veins in group A (94%) and 92 veins in group B (96%; NS). The remaining veins showed partial closure with none showing retrograde flow. Six-month duplex scans were completed in 155 veins. Complete closure was seen in 110 veins in group A (98%) and 43 veins in group B (100%; NS). All veins partially open on early scan had closed by 6 months. The 2 veins open at 6 months in group A were closed on initial scan. CONCLUSIONS: Vein diameter >12 mm had no effect on closure rate with the ClosureFAST catheter.
Authors: Muhammad Yousuf Memon; Ilyas Sadiq; Safdar Ali Malik; Muhammad Bin Zulifqar; Muhammad Saad Malik; Muhammad Hammad Malik Journal: Ann Vasc Dis Date: 2021-12-25